Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain
- Conditions
- Chemotherapy Induced Neuropathic Pain
- Interventions
- Drug: Placebo
- Registration Number
- NCT06848348
- Lead Sponsor
- Dogwood Therapeutics Inc.
- Brief Summary
A randomized study to determine safety and efficacy of single subcutaneous (SC) administration of HAL treatment in patients with CINP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Male or female patients aged ≥18 years.
- Neuropathic pain has been present and is attributed to platinum and/or taxane chemotherapy.
- Patient has received a cancer chemotherapy regimen that included taxanes and/or platinum and has no active or discernible disease progression.
- Current neuropathic pain with symptoms similar to CINP but attributed to causes other than platinum or taxane chemotherapy.
- Patients who have received HAL at any time prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Halneuron Halneuron Halneuron
- Primary Outcome Measures
Name Time Method To explore the efficacy of Halneuron in the treatment of patients with Chemotherapy-Induced Neuropathic Pain From enrollment to end of study at 4 weeks Change from Baseline in the weekly average of daily 24-hour pain intensity scores in patients treated with Halneuron compared to Placebo
To explore the Safety of Halneuron in the treatment of patients with Chemotherapy-Induced Neuropathic Pain From enrollment to end of study at 4 weeks Incidence of serious adverse events (SAEs), adverse events (AEs) and Adverse Events of Special Interests (AESIs)
- Secondary Outcome Measures
Name Time Method Responder analyses for patient global impression of change (PGIC) Enrollment to end of study at week 4 Change from baseline for patient global impression of change (PGIC) items
Determine benefits of Halneuron treatment on non-pain outcomes including sleep quality, fatigue and mood Enrollment to end of study at week 4 Change from baseline to week 4 on the domains of the PROMIS-29
Related Research Topics
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Trial Locations
- Locations (19)
APEX Research Group, LLC
🇺🇸Fair Oaks, California, United States
Profound Research LLC
🇺🇸Pasadena, California, United States
Providence Medical Foundation
🇺🇸Santa Rosa, California, United States
CenExel FCR
🇺🇸Tampa, Florida, United States
Ark Clinical Research
🇺🇸Fountain Valley, California, United States
TOI Clinical Research
🇺🇸Lakeland, Florida, United States
Conquest Research LLC
🇺🇸Orlando, Florida, United States
Paradigm Clinical Research
🇺🇸Wheat Ridge, Colorado, United States
CenExel ACMR
🇺🇸Atlanta, Georgia, United States
Profound Research at OMG Division of Clinical Hematology and Medical Oncology
🇺🇸Farmington, Michigan, United States
Circuit Clinical/ SSM St. Clare Cancer Care
🇺🇸Fenton, Missouri, United States
Medsol Clinical Research Center, Inc
🇺🇸Port Charlotte, Florida, United States
Center for Oncology and Blood Disorders
🇺🇸Houston, Texas, United States
Saint Lukes Hospital
🇺🇸Kansas City, Missouri, United States
Exel Clinical Research
🇺🇸Las Vegas, Nevada, United States
Rubin MD
🇺🇸Garden City, New York, United States
Upstate Clinical Research Associates LLC
🇺🇸Williamsville, New York, United States
CenExel JBR
🇺🇸Salt Lake City, Utah, United States
SSM Health Dean Medical Group
🇺🇸Madison, Wisconsin, United States